Milrinone Lactate
Milrinone Lactate Injection, USP
Approved
Approval ID
0fdaee3c-2144-4ca7-9868-54d251f468c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Shandong New Time Pharmaceutical Co., Ltd.
DUNS: 545298254
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42677-314
Application NumberANDA216373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42677-313
Application NumberANDA216373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT